Scott Hambleton, M.D. Medical Director Mississippi Physician Health Program

The Prescription Drug Abuse Crisis: 2016 Update

2nd Annual Symposium on Addiction Opioid addiction: The Highs, The Highways, The Hope

Lombard. IL September 23, 2016

Todays speaker has no disclosure of real or apparent conflict related to the content of this presentation.

No Disclosures

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1) To describe the epidemiology of prescription drug abuse.

2) To identify factors which have contributed to prescription drug abuse in America.

3) To summarize risks of prescribing controlled substances for chronic, non-life threatening conditions.

Objectives:

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Much of the content of this presentation was made possible by Andrew Kolodny, MD and his work with the Physicians for Responsible Opioid Prescribing

www.supportprop.org

Acknowledgement

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Opioids CNS Depressants Stimulants Other Substances

Classes of Prescription Drugs

*

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Prescribed to alleviate pain

Examples include : • Hydromorphone (,

(Dilaudid®) • Hydrocodone (Vicodin® Lortab ®) • oxycodone (OxyContin®)

Opioids

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55% of all morphine 56% of all hydromorphone 80% of all oxycodone 99% of all hydrocodone Americans represent 5.2% of the

earth’s population (International Narcotics Control Board 2011 Report)

US Consumption of Global Supply of Opioids: 2010

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69 tons of pure oxycodone 42 tons of pure hydrocodone 222,000 pounds

(CDC, 2012)

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111 Tons Dispensed in 2010

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Opioid Prescriptions Dispensed per Year (Oxycodone and Hydrocodone)

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The Eye of the Perfect Storm… The use of opioids for chronic noncancer pain

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Introduction of OxyContin: 1996

Active ingredient: oxycodone Manufactured by Purdue Pharma $48 million in sales

in 1996 (Van Zee, 2009)

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Purdue “aggressively” promoted the use of opioids for use in the “non-malignant pain market.” Targeted primary care “Risk of addiction much less than 1%.” $200 million spent in marketing in 2001

(Van Zee, 2009)

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Industry Marketing

Dollars Spent Marketing OxyContin (1996-2001)

(www.supportprop.org)

OxyContin Sales 2010

$3.1 billion in

sales in 2010 Over $17 billion in sales 2000-

2010 (IMS Health, National Prescription

Audit, Dec 2010) MSPHP.com

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MYTH: Opioid use for chronic non-cancer pain is

supported by strong evidence. FACT: Evidence for long-term use in chronic non-

cancer pain is limited and of low quality. (Murray, 2013; Reuben, 2015)

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Chronic Opioid Therapy (COT) Myths

MYTH: Tolerance an physical dependence only

happens with high doses over long periods of time.

FACT: With daily use, physical dependence and

tolerance can develop in weeks or days. (Volkow & McLellan, 2016)

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Chronic Opioid Therapy (COT) Myths

MYTH: Patients who develop physical dependence on

opioids can easily be tapered off. FACT: Successfully tapering chronic pain patients from

opioids can be difficult – even for those who are highly motivated to discontinue the opioids.

(CDC Guidelines for Prescribing Opioids for Chronic Pain 2016)

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Chronic Opioid Therapy (COT) Myths

MYTH: Addiction is rare in patients receiving medically

prescribed COT. FACT: Rates of misuse, and aberrant drug-seeking

behaviors between 15-26%. (Volkow & McLellan, 2016)

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Chronic Opioid Therapy (COT) Myths

MYTH: Dose-related risk of overdose associated with COT

can be avoided by slow upward titration. FACT: The risk for ANY opioid related overdose event is

dose dependent. CDC Guidelines recommend that clinicians should

avoid increasing dosage to >90MME/day. (CDC Guidelines for Prescribing Opioids for Chronic

Pain 2016)

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Chronic Opioid Therapy (COT) Myths

MYTH: Addiction is the main reason to be concerned

when prescribing opioids. FACT: Other significant risks include respiratory

depression and unintentional overdose, serious fractures from falls, increased pain sensitivity and sleep-disorder breathing.

(National Safety Council WHITE PAPER, 2014)

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Chronic Opioid Therapy (COT) Myths

MYTH: Long acting/extended release opioid

medications have less risk of overdose than short-acting opioid medication.

FACT: Patients initiating therapy long-acting opioids

twice as likely to overdose compared to patients initiating therapy with short-acting opioids.

(Miller M, et al., 2015)

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Chronic Opioid Therapy (COT) Myths

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30

Non-heroin opioid admissions, by gender, age, race/ethnicity: 2011

Source: CDC, Unintentional Drug Poisoning in the United States

.

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Heroin Epidemic

1970s

Source: CDC, Unintentional Drug Poisoning in the United States

.

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Source: CDC, Unintentional Drug Poisoning in the United States

.

.

Cocaine Epidemic

1986-1992

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Source: CDC, Unintentional Drug Poisoning in the United States

.

OxyContin 1996

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Source: CDC, Unintentional Drug Poisoning in the United States

. 5th Vital Sign Implemented

2001

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Source: CDC, Unintentional Drug Poisoning in the United States (2010)

.

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26,389 Deaths in 2006

(CDC, 2012)

.

.

2010

.

38,329 Deaths in 2010

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(CDC, 2014 Mortality Data)

.

2014

.

47,055 Deaths

(All O.D. Deaths)

Patients with mental health and substance abuse co-morbidities are more likely to receive chronic opioid therapy than patients who lack these risk factors.

(Edlund, et al., 2007)

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Adverse Selection

“moderate to severe chronic pain that limits activities and diminishes quality of life.” 25 million Americans (Annals of Internal Medicine. POSITION PAPER. 2015)

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How Many Americans Have Moderate to Severe Chronic Pain?

Patients “initially treated with opioids (for lumbar disc herniation) had a higher rate of surgery and a greater chance of being on opioids four years later but no significant change in overall outcome.

(Radcliff, et al., 2013)

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Opioids for Treatment of Back Pain?

2013 quantitative systematic review in the Journal of the American Dental Association “325 mg of acetaminophen (APAP) taken

with 200 mg of ibuprofen provides better pain relief than oral opioids.”

(Moore, et al., 2013)

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Opioids for Dental Pain After Wisdom Tooth Extraction?

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Oxycodone 15 Oxycodone 10 +Acetaminophen 650

Naproxen 500 Ibuprofen200+Acetaminophen 500

NNT to get 50% pain reduction

4.6

2.7 2.7

1.6

Number Needed to Treat (NNT)

(National Safety Council: Evidence for the Efficacy of Pain Medication, 2014)

Prescription Drug Abuse Crisis

Minimization of addictive

potential of opioids

Lack of sufficient education about addiction

Boundary Failure

What is a Boundary?

“A line in the sand that represents the edge of appropriate, professional conduct.”

(Gutheil & Gabbard, 1993)

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7TH International Conference on Pain and Chemical Dependency

June 2007 MSPHP.com

Heroin

Sold over the counter by German drug company Bayer in 1895 to cure morphine addiction

“a non-addictive morphine substitute and cough suppressant”

Heroin rapidly metabolizes into morphine.

US Senate investigation resulted in guilty plea on May 10, 2007

Misled regulators, doctors and patients about the enormous addiction and abuse potential of OxyContin

(United States DOJ, 2008)

Purdue Pharma Pays $634.5 Million

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January 2009 $1.4 Billion

September 2009 $2.3 Billion

May 2012 $1.5 Billion

July 2012 $3 Billion

November 2013 $2.2 Billion

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“Drug companies spend 19 times more

on marketing than Research & Development.”

(Light & Lexchin, BMJ, 2012)

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R & D Costs for New Drugs

0

0.5

1

1.5

2

2.5

3

02 12 13

2.7% 7 Million 2.5%

(6.5 Million)

2002 2012 2013

Current Illicit Prescription Drug Use

(NSDUH, 2013)

1.9%

1

100,001

200,001

300,001

400,001

500,001

600,001

700,001

800,001

900,001

1,000,001

2003 2013 2014

681,000

314,000

914,000

Past Year Heroin Use

(NSDUH, 2014)

Past Year Heroin Use

75% of heroin users report previous abuse of opioid

pain medication

(SAMHSA, 2014 NSDUH )

CDC Guideline for Prescribing Opioids for Chronic Pain - 2016

No evidence shows a long-term benefit of opioids in pain and function versus no opioids for chronic pain with outcomes examined at least 1 year later (with most placebo controlled randomized trials ≤6 weeks in duration) http://www.cdc.gov/drugoverdose/pres

cribing/resources.html

CDC Guideline for Prescribing Opioids for Chronic Pain - 2016

Extensive evidence shows the possible harms of opioids (including opioid use disorder, overdose, and motor vehicle injury) http://www.cdc.gov/drugoverdose/pres

cribing/resources.html

CDC Guideline for Prescribing Opioids for Chronic Pain - 2016

Extensive evidence suggests some benefits of nonpharmacologic and nonopioid pharmacologic treatments compared with long-term opioid therapy, with less harm http://www.cdc.gov/drugoverdose/pres

cribing/resources.html

CDC Guideline: 12 Recommendations in Three Areas

Determining when to initiate or continue opioids for chronic pain. Opioid selection, dosage, duration, follow-up, and discontinuation. Assessing risk and addressing harms of opioid use. http://www.cdc.gov/drugoverdose/prescri

bing/resources.html

Thank You!

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Acknowledgements: Andrew Kolodney, MD et al. Physicians for Responsible Opioid Prescribing. http://www.supportprop.org/about/index.html.

Centers for Disease Control and Prevention. National Center for Health Statistics 2014 Mortality Data. http://www.cdc.gov/nchs/deaths.htm. Accessed September 16, 2016.

CDC Guidelines for Prescribing Opioids for Chronic Pain – United States 2016. http://www.cdc.gov/drugoverdose/prescribing/resources.html. Accessed September 13, 2016.

Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses — a U.S. Epidemic. Morbidity and Mortality Weekly Report. 2012; 61(01); 10-13. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm. Accessed September 12, 2016.

REFERENCES:

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Centers for Disease Control and Prevention. Release of issue brief: Unintentional drug poisoning in the United States. Morbidity and Mortality Weekly Report. 2010; 59(10); 300. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5910a5.htm. Accessed September 16, 2016.

Edlund MJ, stef fick D, Hudson T, Harris KM, Sullivan M. Risk factors for cl inically recognized opioid abuse and dependence among veterans using opioids for chronic non-cancer pain. Pain . 2007; 129(3):355-62. doi: 10.1016/j.pain.2007.02.014.

Gutheil TG, Gabbard GO. The concept of boundaries in cl inical practice: theoretical and risk-management dimensions. Am J Psychiatry . 1993;150(2):188-96. doi: 10.1176/ajp.150.2.188.

IMS Health, National Prescription Audit, Dec 2010. http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_report%20.pdf.Accessed February 19, 2013.

International Narcotics Control Board. Report 2011. Estimated world requirements for 2012. http://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2011/Part_FOUR_Complete_English-NAR-Report-2011.pdf. Accessed September 12, 2016.

REFERENCES, CONT’D.

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Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012; 345. e4348. doi: 10.1136/bmj.e4348.

Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions. JADA . 2013; 144(8): 898-908. doi: 10.14219/jada.archive.2013.0207.

Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015; 175(4):608-15. doi: 10.1001/jamainternmed.2014.8071.

Murray C. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors . JAMA. 2013; 310(6), 591–608. doi:10.1001/jama.2013.13805

REFERENCES, CONT’D.

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Teater D. National Safety Council . Evidence for the efficacy of pain medications. http://safety.nsc.org/painmedevidence. Published 2014. Accessed September 16, 2016.

Substance Abuse and Mental Health Services Administration: Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf. Published September 2015. Accessed September 16, 2016.

Radclif f K, Freedman M, Hilibrand A, et al. Does opioid pain medication use affect the outcome of patients with lumbar disc herniation? Spine. 2013; 38(14): 849–860. doi:10.1097/BRS.0b013e3182959e4e.

Reuben DB, Alvanzo AA, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain. Annals of Internal Medicine. 2015; 162:295-300. doi:10.7326/M14-2775.

REFERENCES, CONT’D.

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U.S. General Accounting Office: Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem (GA0-04-110), Washington, DC, U.S. General Accounting Office, 2004. http://www.gao.gov/new.items/d04110.pdf. Accessed September 16, 2016.

United States Department of Justice. Office of the Deputy Attorney General. Pharmaceutical Marketing Fraud Under the False Claims Act. https://www.justice.gov/sites/default/files/usao/legacy/2009/01/29/usab5701.pdf. November 7, 2008. Accessed September 16, 2016.

Volkow ND & McLellan AT. Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies. N Engl J Med . 2016; 374:1253-1263. doi: 10.1056/NEJMra1507771

Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. Am J Public Health . 2009; 99(2): 221–227. doi: 10.2105/AJPH.2007.131714.

REFERENCES, CONT’D.

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American Society of Addiction Medicine(ASAM): www.asam.org/ Centers for Disease Control and Prevention:

www.cdc.gov/ Centers for Disease Control , storage and disposal

guidelines: www.cdc.gov/HomeandRecreationalSafety/poisoning/preventiontip.htm Mississippi Professionals Health Program:

www.msphp.com National Institute on Drug Abuse(NIDA):

www.nida.nih.gov/infofacts/PainMed.html

RESOURCES

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Office of National Drug Control Policy(ONDCP): ww.whitehousedrugpolicy.gov/DrugFact/index.html Physicians for Responsible Opioid Prescribing:

http://www.supportprop.org Scott Hambleton, MD; Medical Director, Mississippi

Professionals Health Program; 408 West Parkway Place, Ridgeland, MS, 39157. (601)420-0240. shambleton@msphp.com Substance Abuse & Mental Health Services

Administration(SAMHSA) www.samhsa.gov/ US Drug Enforcement Agency(DEA): www.usdoj.gov/dea

RESOURCES

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